Kornimate/medical-research-clean huggingface dataset:
the influence of demographic parameters and acl injury on the association among clinical, functional and biomechanical parameters

Conditions: Anterior Cruciate Ligament (ACL) Injury

Summary: this retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after acl injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the ethikkommission nordwestschweiz (eknz 2019-00491, eknz 2019-01315, eknz 2020-00551). the primary research question analyzes if maximal slh distance and lsislh distance are related to the predictors age, sex, isokinetic muscle strength and the presence of injury.

injury of the anterior cruciate ligament (acl) is one of the most common injuries of the knee. acl reconstruction using auto- and allografts is still the gold-standard technique and widely used in the surgical treatment of acl ruptures. potential deficits in the affected leg are frequently evaluated using the limb symmetry index (lsi) calculated as performance affected side/performance unaffected side x 100. several factors other than injury may influence single leg hop (slh) distance and lsi such as sex, age, and muscle strength. this retrospective study aims at analysing demographics and clinical, functional and biomechanical outcomes in patients after acl injury (conservative therapy and/or surgery) in patients of different ages and healthy controls. demographics, as well as clinical, functional and biomechanical parameters were collected between 2019 and 2022 in two research projects approved by the ethikkommission nordwestschweiz (eknz 2019-00491, eknz 2019-01315, eknz 2020-00551)

Eligibility criteria:
inclusion criteria: * patients: 2-10 years since acl injury * control subjects: no previous injury to the meniscus or the ligament apparatus of the knee exclusion criteria: * bilateral injury or previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months * concomitant conditions that affect the mobility of the knee (e.g., neuromuscular diseases that affect lower limb movement, injury of the posterior cruciate ligament (pcl), more than one collateral ligament ruptured, fracture, luxation of the knee, tumorous disease, immunosuppressed patients) * inability to give informed consent

Keywords: limb symmetry index (lsi) muscle strength single leg hop (slh) distance leg symmetry index for slh (lsislh distance)
enhanced recovery programs and small bowel obstruction

Conditions: Small Bowel Obstruction; Surgery

Summary: small bowel obstruction surgery is frequent and would benefit from enhanced recovery programs. while some studies advocate for their feasibility, it has never been proved and prospective studies are required to confirm the feasibility of such program and the impact on postoperative outcomes.


Eligibility criteria:
inclusion criteria: * adhesionnal small bowel obstruction requiring surgical management exclusion criteria: * no surgery * patients disagreeing to participate
safety, tolerability, pharmacokinetics and pharmacodynamics of acz885 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to evaluate, in patients with type 2 diabetes mellitus, whether canakinumab can lower glycosylated hemoglobin / hemoglobin a1c (hba1c) and/or peak glucose levels in response to an oral glucose tolerance test (ogtt).


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start * hba1c between 7.0 and 9.5% * on stable dose metformin monotherapy * stable body weight exclusion criteria: * poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control) * acute infections prior to dosing * patients with type 1 diabetes (insulin-dependent diabetes) * taking diabetes medication (other than metformin) other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes mellitus canakinumab acz885 il-1b antagonist metformin glycemic control insulin sensitivity
a phase 2, open-label study of absk-011 combined atezolizumab in hcc patients

Conditions: Hepatocellular Carcinoma

Summary: this study is an open phase ii clinical study, which consists of part a and part b. part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable hcc to and pk/pd characteristics, and determine the treatment plan of part b. part b will evaluate absk-011 combined with atilizumab anti fgf19 overexpression in advanced stage or non resectable patients who have not received systemic therapy or only received first-line systemic therapy before in addition to the safety and tolerability of hcc subjects, the antitumor activity of the combination will be further evaluated.

during part a, all subjects will receive continuous oral administration of absk-011 once a day (qd) or twice a day (bid) with an initial dose of 180 mg, and intravenous infusion (iv) of 1200 mg of atilizumab every 21 days (q3w). after the first subject (sentinel subject) in each dose cohort completed the first combined medication, follow-up subjects were administered at least 7 days later. part b will include subjects with advanced unresectable hcc who have not previously received systemic therapy or only received first-line systemic therapy and whose fgf19 expression is positive. no more than 70% of the enrolled subjects have only received first-line systemic therapy

Eligibility criteria:
inclusion criteria: 1. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. subjects should be able and willing to follow the study follow-up and study procedures in the protocol. 2. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old. 3. part a: subjects with advanced or unresectable hcc who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child pugh score is 5-6. part b: subjects with advanced or unresectable hcc who must be confirmed histologically or cytologically, are not suitable for curative surgery and / or local regional treatment, and have not previously received systematic treatment or only received first-line systematic treatment- exclusion criteria: 1. history of autoimmune diseases 2. have a history of the second primary malignant tumor other than hcc within 5 years before screening, 3. have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels. 4. meningeal metastasis or central nervous system (cns) metastasis -
trial to evaluate efficacy and safety of lib003 and inclisiran in high-risk cvd patients

Conditions: Hypercholesterolemia; Atherosclerotic Ischemic Disease

Summary: comparison of ldl-c reductions of lerodalcibep (lib003) 300 mg to inclisiran (leqvio®) 284 in patients at very-high risk or high-risk for cvd on stable diet and oral ldl-c-lowering drug therapy

randomized, open label (lipids blinded), phase 3 study to evaluate the efficacy and safety of lerodalcibep (lib003) at day 270 of subcutaneous (sc) monthly (qm \[≤31 days\]) lerodalcibep (lib003) 300 mg administered to sc inclisiran (leqvio®) 284 mg at days 1 and 90 in patients with very-high risk or high-risk cvd or at high risk for cvd with ldl-c ≥85 mg/dl on a stable diet and oral ldl-c-lowering drug therapy

Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study-specific procedure; * weight of ≥40 kg (88 lb) and body mass index (bmi) ≥16 and ≤42 kg/m2; * very- high or high risk for cvd as defined in 2019 esc/eas guidelines * high-intensity statin (daily atorvastatin 40/80 or rosuvastatin 20/40) without other acceptable oral lipid lowering treatment plus diet; stable \>4 weeks with ldl-c ≥85 mg/dl and triglycerides ≤400 mg/dl * women of childbearing potential (wocbp) must continue using a highly effective form of birth control if sexually active * males whose partners are of cbp and not using a highly effective form of birth control will either be surgically sterile or agree to use the following forms of contraception, male or female condom with spermicide exclusion criteria: * prior or active clinical condition or acute and/or unstable systemic disease, including cancer, compromising patient inclusion or preclude completion of the study, at the discretion of the investigator * homozygous fh * non-high intensity statins, mipomersen, lomitapide, gemfibrozil, and bempedoic acid * pcsk9 mab within 4 weeks of screening or sirna within 1 year * severe renal dysfunction, defined egfr \<30 ml/min * recent, within 3 months of screening, atherosclerotic event or intervention * planned cardiac procedure * nyha class iii or iv heart failure * active liver disease * uncontrolled diabetes defined as fasting glucose \>200 mg/dl and hba1c \> 9% * uncontrolled bp ≥180 mmhg systolic or ≥110 mmhg diastolic;

Keywords: lerodalcibep pcsk9 inhibitor inclisiran
lifup for treatment of motor deficits in parkinson&#39;s disease

Conditions: Parkinson Disease

Summary: the study will test the feasibility of using low intensity focused ultrasound pulsation (lifup) to treat motor symptoms in parkinson's disease (pd). lifup is a new technique that can increase brain activity in highly specific target areas and is mri compatible. thus, in real-time, it is possible to directly observe how lifup changes the brain areas important in pd by measuring its effects on brain activity, blood flow, and brain connectivity. if successful, this research will mark the first step towards a novel, non-invasive, non-medication treatment for pd.

this trial is a proof-of-concept, proof-of-mechanism study of a novel neuromodulation technology - lifup - to treat motor symptoms in pd. much like deep brain stimulation, lifup can be focused on deep brain structures with high spatial accuracy, including those implicated in pd; however, it can do so non-invasively. other non-invasive neuromodulation tools such as transcranial magnetic stimulation can only target surface brain structures and are not optimal pd treatment tools. this study will test this new technology in 30 participants with pd during simultaneous resting state functional mri, and collect pre- and post-lifup functional mri, arterial spin labeling, motor performance data, and behavioral data, in a double-blind crossover trial to determine whether lifup: 1) will improve motor symptoms during and after treatment; 2) can modulate neural activity in the target brain region important for pd, the internal globus pallidus; and 3) enhance cortico-striatal motor circuit connectivity. all participants in this study will receive active ultrasound at one of the two in-person sessions and sham at the other.

Eligibility criteria:
inclusion criteria: 1. diagnosis of parkinson's disease 2. age 18-85 3. fluent in the english language exclusion criteria: 1. metal implants that are not mr compatible 2. neurological diagnosis other than parkinson's 3. not fluent in the english language

Keywords: lifup ultrasound
delirium assessment in the pediatric intensive care unit

Conditions: Pediatric Delirium

Summary: objective: studies documenting the prevalence of delirium among critically ill children are still rare. emerging literature from psychiatric specialists reports the prevalence of delirium to be approximately 10% in the pediatric intensive care unit (picu). this is likely to be an underestimation of the true prevalence, as demonstrated in early adult delirium literature, especially given the absence of validated bedside tools to diagnose delirium in the picu. the primary aim of this study is to validate the german version of the pediatric confusion assessment method for the intensive care unit (pcam-icu). the secondary aim of the study is to compare validity and reliability of the pcam-icu and the pediatric anesthesia emergence delirium (paed) scale.


Eligibility criteria:
inclusion criteria: * pediatric icu patients exclusion criteria: * non-german-speaking * inability to communicate due to severe hearing loss or brain injury * preexisting psychosis * mental retardation due to a specific diseases (e.g. m. crouzon, kabuki syndrome, z.n. battered child, atrogryposes multiplex congenita)
a study of tarceva (erlotinib) in sequential combination with gemcitabine as first line therapy in patients with advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this 2 arm study will compare the efficacy and safety of sequential treatment with tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ecog performance status of 2, with advanced non-small cell lung cancer.patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=70 years of age or with ecog ps of 2; * advanced (stage iiib or iv)non-small cell lung cancer; * no prior systemic chemotherapy for advanced nsclc or prior treatment with her-axis targeted drugs. exclusion criteria: * active brain metastasis or spinal cord suppression; * unstable systemic disease.
effect study of tigecycline to treat severe sepsis and septic shock

Conditions: Abdominal Infection

Summary: selection of tigecycline in severe sepsis and septic shock patients in empirical antibiotic therapy (hai zheng energy star ®) combined with piperacillin / tazobactam (tazocin ®) scheme, compared with the classical scheme, evaluate its efficacy, safety index.

tigecycline as representative glycylcycline antibiotics, has wide antibacterial spectrum and strong antibacterial activity, tigecycline in almost all of the gram positive bacteria and most gram negative bacteria and atypical pathogens, anaerobic bacteria are very good antibacterial activity except pseudomonas aeruginosa, proteus. safety on organ function, in patients with renal insufficiency or in dialysis patients, no dose adjustment is required application of tigecycline, mild to moderate hepatic insufficiency patients do not need to adjust the dose of tigecycline. piperacillin / tazobactam also is a broad spectrum, potent antibiotics, especially strong bactericidal activity against pseudomonas aeruginosa, including resistant enzyme producing gram negative bacilli, in accordance with its pharmacokinetic pharmacodynamic characteristics of prolonged infusion time can obtain a stronger bactericidal activity. these two potent drugs have broad antimicrobial spectrum, strong bactericidal activity, and provide for the treatment of severe sepsis and septic shock a new choice in antibiotic selection, to a certain extent reduces the resistance pressure, and have more clinical safety.

Eligibility criteria:
inclusion criteria: * be consistent with severe sepsis and septic shock diagnosis standards * age above 18 years old, is expected in more than 5 days in icu * apacheⅱ score\>15 * by the patients themselves or their authorized person agreed to participate in the clinical trial and signed the informed consent exclusion criteria: * allergic to penicillin, or of tigecycline allergic patients * patients with abnormal liver function is severe * be pregnant or lactating women * be not signed the informed consent of patients * any can be expected to increase patient risk or other factors can interfere with the results of a clinical trial

Keywords: sepsis shock tigecycline piperacillin / tazobactam abdominal infection
cabergoline versus gnrh antagonist rescue and cabergoline in the prevention of ovarian hyperstimulation syndrome

Conditions: OHSS

Summary: the aim of study is to compare the efficacy of gnrh antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for ivf-et with long gnrh agonist protocol.

ovarian hyperstimulation syndrome (ohss) is the most serious complication of assisted reproduction. complications of ohss include vascular thrombosis, pulmonary embolism, renal failure, electrolyte disturbances, ascites, hydrothorax ,torsion of the ovary, abortion or rarely death. previous studies revealed that converting a long gnrh agonist cycle to an gnrh antagonist cycle (gnrh antagonist rescue) reduced the risk of ohss. other studies revealed that cabergoline (potent dopamine receptor agonist on d2 receptors)was effective in preventing ohss. the aim of study is to compare the efficacy of gnrh antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for ivf-et with long gnrh agonist protocol.

Eligibility criteria:
inclusion criteria: * patients undergoing ovarian stimulation for ivf-et with long gnrh agonist protocol and at high risk of developing ohss \[ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml\] exclusion criteria: * fibrosis of lung, * swelling or inflammation around the heart or lung, * hypertension, * liver disease, * heart valve disease and * allergy to cabergoline or ergot derivatives.

Keywords: ohss infertility cabergoline gnrh antagonist ivf-et
levemir-body composition and energy metabolism

Conditions: Type 2 Diabetes

Summary: the objectives is to compare the changes in body composition (primary objective), diabetes parameters, energy expenditure and energy intake between insulin detemir (levemir® - novolin® 4 pen) and insulin glargine (lantus® - solostar®) both in combination with metformin and insulin secretagogues (su) between baseline and after 6 months of insulin therapy in 80 type 2 diabetic patients failing on oral diabetic agents .


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients who require basal (long-acting) insulin for the control of hyperglycemia according to the opinion of the investigator. * inadequate glucose control: hemoglobin a1c (hba1c) percentage in the range of ≥ 7.5 - 12.0% * stable body weight for previous 3 months (± 5 kg). * structured exercise lower than 4 hours per week. * metformin ≥1.5 g/day exclusion criteria: * any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol. * type 1 diabetes mellitus * previous treatment with insulin (\< 6 months prior inclusion). insulin therapy for less than 6 days at the time of an acute event is acceptable. * secondary diabetes mellitus (i.e. steroid induced, cushing syndrome, chronic pancreatitis, cystic fibrosis, etc.) and maturity-onset diabetes of the young * proliferative retinopathy/maculopathy requiring treatment * hypoglycemia unawareness or recurrent major hypoglycaemia * pregnancy and breast-feeding * unstable coronary artery disease * heart failure as defined by class iv according to nyha classification * recent (\< 6 months) history of myocardial infarction, stroke or t.i.a, ventricular arrhythmias, or unstable supra-ventricular arrhythmias. * renal insufficiency. creatinine clearance \< 40 ml/min (mdrd formula). * acute (\< 2 months) or chronic infectious diseases requiring either hospitalization or antibiotic treatment for more than 2 weeks * recent (\< 1 year) diagnosis of systemic malignancies except thyroid and skin cancer * major psychiatric diseases * history of drug addiction * previous bariatric surgery * medication that affects weight such as * systemic corticosteroids (prednisone) * anti-obesity medication (xenical® or meridia®) * megace ® * antidepressant medication associated with significant weight impact such as zyprexa®, remeron® based on investigator judgment. * growth hormone therapy or testosterone supplementation should be initiated for at least 6 months and at stable dose for 3 months prior to enrolment * medication that affects glycemic control and hypoglycemic unawareness based on investigator judgment.

Keywords: insulin initiation oral therapy failure
evaluating the relationship between skin color and pulse oximeter accuracy in children

Conditions: Pediatric ALL; Cardiac Defect

Summary: this multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. some studies in adults show that skin color may also affect the pulse oximeter reading. in this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. the study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.

this multisite, prospective, observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization. the primary aim of the study is to quantify pulse oximeter accuracy in children with varying skin colors. children undergoing cardiac catheterization are a unique population in which to study pulse oximeter accuracy because they have a wide range of baseline arterial oxygen saturations secondary to their cardiac conditions, allowing for evaluation of pulse oximeter accuracy across a range of arterial oxygen saturations. children undergoing cardiac catheterization are continuously monitored with pulse oximeters and also have direct measurement of arterial blood oxygen via co-oximeter as part of routine care. the results of this study will contribute much needed knowledge about pulse oximeter accuracy in children to better understand potential clinical implications. dimensions of skin colors (melanin index, redness etc) will be objectively measured using spectrophotometry. during and after the catheterization procedure, clinical data already collected during the course of clinical care will be recorded by the study team, including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure. the primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen.

Eligibility criteria:
inclusion criteria: * child is between 1 month and 18 years old * child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation. exclusion criteria: * child previously participated in the study * child has differential cyanosis across extremities * child is receiving an intravenous vasoconstrictor prior to procedure * child has a ventricular assist device (vad)

Keywords: pulse oximetry